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Activity Number: 333
Type: Contributed
Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #313527 View Presentation
Title: Implications of Heterogeneous Risk on Estimation of Mark-Specific Vaccine Efficacy for Leaky Vaccines
Author(s): Paul T. Edlefsen*+
Companies: Fred Hutchinson Cancer Research Center
Keywords: sieve analysis ; leaky ; vaccine efficacy ; heterogeneous risk ; mark-specific
Abstract:

``Leaky'' vaccines are those for which vaccine-induced protection reduces infection rates on a per-exposure basis, as opposed to ``all-or-none'' vaccines, which reduce infection rates to zero for some fraction of subjects, independent of the number of exposures. Leaky vaccines therefore protect subjects with fewer exposures at a higher effective rate than subjects with more exposures. This simple observation has serious implications for analysis methodologies that rely on the assumption that the vaccine effect is homogeneous across subjects. We argue and show through examples that this heterogeneous vaccine effect leads to a violation of the proportional hazards assumption, to incomparability of infected cases across treatment groups, and to non-independence of the distributions of the competing failure processes in a competing-risks setting. We discuss implications for vaccine efficacy estimation, correlates of protection analysis, and mark-specific efficacy analysis (also known as sieve analysis).


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